PathVisionXL
FDA 510(k) clearance K183142 · decided 2019-03-14
Clearance details
- K-number
- K183142
- Device name
- PathVisionXL
- Applicant
- Faxitron Bioptics, LLC
- Decision
- Substantially Equivalent
- Date received
- 2018-11-13
- Decision date
- 2019-03-14
- Days to decision
- 121 days
- Clearance type
- Traditional
- Product code
- MWP
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Tucson, AZ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Faxitron Bioptics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US) (K230140) | Compai Healthcare (Suzhou) Co.,Ltd | 2023-04-24 |
| TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US) (K230136) | Compai Healthcare (Suzhou) Co.,Ltd | 2023-04-24 |
| Solas OR (K213691) | Cirdan Imaging, Ltd. | 2021-12-22 |
| Kubtec Mozart Supra (XPERT 84) Radiography System (K210955) | Kub Technologies, Inc. | 2021-09-20 |
| Kubtec Mozart (XPERT42) (K210956) | Kub Technologies, Inc. | 2021-08-31 |
| Kubec Xpert 80 Radiography System (K210957) | Kub Technologies, Inc. | 2021-08-31 |
| TrueView 100 Pro (K202713) | Compai Healthcare (Shenzhen) Co.,Ltd | 2020-11-18 |
| Kubtec Mozart Supra (K200756) | Kub Technologies, Inc. | 2020-06-12 |
| Volumetric Specimen Imager (K192939) | Clarix Imaging | 2019-12-27 |
| CoreLite X-Ray Specimen Cabinet (K193317) | Cirdan Imaging Limited | 2019-12-13 |
| Kubtec Mozart (Xpert42) (K183624) | Kub Technologies, Inc. | 2019-06-20 |
| Trident HD Specimen Radiography System (K182727) | Hologic, Inc. | 2019-01-10 |
Recalls involving this device
No recalls on record reference this clearance.